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Pharmaceutical process development involves multi-disciplinary groups of chemists and analysts whose goal it is to create the API by the cheapest, most efficient route while ensuring product safety through effective impurity control measures.
Liquid chromatography is an analytical technique utilised widely in the pharmaceutical industry. How does it work and what other methods can it be combined with to enhance its uses?
A typical cleaning validation (CV) programme consists of three phases: Design, Validation and Continued Verification.
19 February 2020 | By SUEZ
Watch our on-demand webinar which will guide you through efficiency gains with TOC for cleaning validation. We call it a ‘beginner’s guide’, but this webinar will benefit long-time TOC users as well as those new to using TOC for cleaning validation.
Over the last decade, Transmission Raman spectroscopy (TRS) has been increasingly implemented in pharmaceutical laboratories as a highspeed, accurate, quantitative analysis solution.
What’s the difference between High Performance Liquid Chromatography (HPLC) and Ion Chromatography (IC)? What are the capabilities and limitations of each technique? Knowing these differences can actually make a huge difference.
19 September 2019 | By SUEZ
This webinar will present how to easily evaluate "fitness for purpose" of a TOC instrument for compendial water and cleaning validation applications based on USP and ICH Q2(R1).
This free poster compiles all basic chromatography principles needed to develop and run flash and prep HPLC methods.
Genotoxic impurities (GTI’s) are intermediate, reactive products or degradants formed during drug synthesis, formulation or storage.
Comparison of the Sartorius Claristep Filtration System with standard sample preparation using syringe filters.
The efficacy, safety and pharmacokinetic properties of a protein therapeutic substantially depend on the molecule having the right structure. This article reviews current methods used for obtaining higher order structure information of biotherapeutics.
There is an increasing need for purified materials in the development and production of pharmaceutical products. FDA and other regulatory agencies continue to require more stringent purity requirements on active pharmaceutical ingredients (API), including most recently chiral purity.
HPLC is critical to the discovery, development and eventual commercialization of pharmaceutical products. HPLC is the benchmark analytical method in the pharmaceutical industry due to its ability to score such high marks in analytical validation characteristics; including accuracy, precision, limit of detection, specificity, linearity and range, and ruggedness.
Generic screening to provide fast solutions for chiral method development, whether needed for routine analytical use, trace analysis, LC/MS or preparative LC, has become increasingly important.
This whitepaper demonstrates the High Performance Liquid Chromatography (HPLC) separation and analysis technique and highlights the importance of using water of sufficient purity as an eluent and how the arium® pro VF system can facilitate this.
